Food and Drug Administration advisers on Friday
voted against allowing the cholesterol-lowering medication Pravachol (pravastatin), made by
Bristol-Myers Squibb, to be sold directly to consumers in pharmacies.
On Thursday, the same advisers voted against switching Merck & Co.'s cholesterol-lowering
drug Mevacor (lovastatin) from prescription to over-the-counter (OTC) use.
Panelists said that Pravachol was very safe, as long as people who have heart disease or
diabetes don't take the drug. They also said that the company almost swayed them that
consumers could safely and effectively use Pravachol without stringent oversight from
"This product comes really close to what I'd like to see," said panelist Marie Gelato of the State
University of New York at Stonybrook's Health Science Center.
She and other committee members recommended that Bristol-Myers study again how well
consumers understand OTC Pravachol's label and that they target a narrower patient
population. Bristol-Myers was recommending that Pravachol, 10 mg a day, be used in men over
age 35 and women over age 45 who had total cholesterol of 200-240 mg/dl and LDL, or "bad"
cholesterol greater than 130 mg/dl.
Although the agency is not bound by the panel's recommendation, the FDA usually follows its
Both Bristol-Myers and Merck argued that if their products were more widely available, more
consumers would seek treatment for elevated cholesterol, a risk factor for cardiovascular
Most people with total cholesterol of 200-240 mg/dl are told to change their diets and increase
exercise to reduce total cholesterol and LDL. There is some debate whether these people are at
higher risk for heart disease, heart attacks, and strokes. Bristol-Myers Squibb consultant
Jerome Cohen of the St. Louis University Preventive Cardiology Program argued that they are
and that they should be treated.
"We should strive for an optimal cholesterol level," said Cohen, noting that the National
Cholesterol Education Program describes those optimal values as less than 200 mg/dl for total
cholesterol and less than 130 mg/dl for LDL.
In considering a drug for OTC use, the FDA looks at safety and efficacy, and whether the target
population will appropriately use the product, and whether they will understand how to take
proper doses, how long to take the drug, and the long term benefits, said David Orloff, deputy
director of the FDA's division of metabolic and endocrinologic drugs.
These questions are especially important for Pravachol, since, unlike other OTC drugs, it is for
a condition that has no symptoms and is potentially life-threatening, he said.
Bristol-Myers conducted several studies that it said showed that consumers would understand
who should and should not take Pravachol and that they should consult with a physician when
taking the drug.
Karen Lechter of the FDA's Division of Drug Marketing, Advertising and Promotion, agreed that
these points were well understood. But, she said, it wasn't clear if the study subjects
understood the need for dietary and lifestyle changes in addition to Pravachol, and if they knew
what's considered a healthy cholesterol level. There is also some potential for misuse, she said,
noting that 17% said that Pravachol was appropriate for total cholesterol of 250-300 mg/dl.
Bristol-Myers also studied whether people would follow directions in both a contrived pharmacy
situation and a "real-world" retail setting. The vast majority of OTC purchasers in both studies
had been told they had high cholesterol, and thus appropriately self-diagnosed and bought
Pravachol, said Bristol-Myers.
Most patients also consulted a physician within 2 months of starting the drug. The company
also said that most had a reduction in cholesterol levels that brought them in line with NCEP
The FDA, though, pointed out that only half the patients taking Pravachol in both studies took
their medication as recommended on the label, which means that benefits might not be
long-lasting. The agency also questioned whether people could self-diagnose with high
cholesterol, pointing out that 21% of those queried in one Bristol-Myers study did not know a
healthy total cholesterol level was under 200 mg/dl.